None listed
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company(HWC)
Eligibility
Inclusion criteria
Inclusion criteria: Adults who meet all the following criteria will be included in the study. 1. Healthy adult male or female aged between 18 to less than 45 years with normal body mass index (BMI) 18.5-24.9 kg/m2. 2. Healthy adults as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests-as specified in Appendix1. 3. Healthy adults who refrain from taking any oral and topical medication at least 15 days prior and during the study period-SOS medications to be allowed during the study for any specific medical condition like paracetamol for fever. 4. Healthy adults who have not participated in any other similar clinical study within the last 3 months of screening. 5. Healthy adults who willingly sign informed consent and follow the study procedure.
Exclusion criteria
Exclusion criteria: Adults who meet any of the following criteria will be excluded from the study. 1. Patients with known clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, congenital or any other systemic disorder that can interfere with the study conduct and outcome in the opinion of the Investigator. (Patients with any chronic medical condition under control to be also excluded). 2. Patients with known history of GIT disorders like GERD, Gastritis, abdominal pain, diarrhea, indigestion, or any other discomfort (as assessed by GSRS score (Appendix 2) more than 1 for any one of the 15 questions to be excluded). 3. Patients with known fatty liver disease grade 2 or more, history of chronic liver disease (like ALD/ DILI/MASLD, chronic viral hepatitis like hepatitis B, C). 4. Patients with known history of acute liver disease like acute hepatitis, within 6 months prior to the study (1) 5. Patients with history of major surgery (like cholecystectomy) and major procedures like MRCP, ERCP. 6. Patients with pre-existing systemic diseases (auto immune disorders, hormonal replacement etc.) necessitating long-term medications. 7. Patients with any current infections (bacterial, fungal, viral) at the time of screening as determined by the investigator. 8. Pregnant as assessed by UPT & history of amenorrhea and lactating women. 9. Women of child-bearing potential who refrain to use adequate contraception throughout the study period. 10. Males who refrain to use adequate contraception throughout the study period and not willing to refrain from donating sperm from first admission to the study until 90 days after the study completion. (2) 11. Adults who are not willing to refrain from alcohol or smoking from 48 hours prior and during the study. 12. Adults who undergo strenuous exercise within 7 days prior and during the study. (3) 13. Known alcohol, any other substance abuse or any other reason (physical, psychological, or social) that can interfere with the participant s compliance to the study in the opinion of the Investigator. 14. Patients with known history or present condition of allergic response to any of the ingredients in the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events during the study period. 2. Proportion of participants withdrawing from trial because of adverse events (tolerability) 3. Gastrointestinal (GI) tolerability during the study period.Timepoint: Day 1 and Day 7 +1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr Soorya Naryanan
Himalaya Wellness Company(HWC)
Outcome results
None listed